Urbason 16 mg
Urbason 16 mg
30 tabletsActive ingredient: methylprednisolone
What is it and how is it used?
The active ingredient of Urbason is methylprednisolone, an artificially produced glucocorticoid. Glucocorticoids are endogenous hormones formed in the adrenal cortex and affect the metabolism of almost all tissues. In case of insufficient or lack of function of the adrenal cortex Methylprednisolone replaces the body's own hormone cortisol. In higher doses Urbason reduces inflammation and suppresses the immune system of the body.The effect of methylprednisolone in airway constriction is essentially based on the inhibition of inflammatory processes, suppression or reduction of mucosal swelling (edema), inhibition of bronchoconstriction, inhibition or restriction of mucus production and liquefaction of the mucus.
Urbason 16 mg tablets are used:
in severe rheumatic diseases (active rheumatoid arthritis, juvenile idiopathic arthritis, acute rheumatic fever),
in paroxysmal dyspnea (asthma)
with severe hay fever (pollinosis) or hay fever, if there is no improvement with a glukokortikoidhaltigen nasal spray,
in certain skin or mucosal disorders that can not or are not adequately treated with glukokortikoidhaltigen ointments / creams / solutions
certain blood diseases (autoimmune hemolytic anemia, idiopathic thrombocytopenia, acute forms of leukemia and lymphoma - in combination with other drugs)
for the prevention or treatment of emesis due to cancer therapy,
as adjunctive treatment of severe kidney disease (eg. as glomerulonephritis, lupus nephritis, nephrotic syndrome)
Insufficient or lack of function of the adrenal cortex (as a treatment option in Addison'scher disease first drug of choice is hydrocortisone, the doctor will prescribe additional mineralocorticoids)
to prevent rejection after organ transplantation,
as a complementary treatment with radiotherapy or chemotherapy.
What you need to consider before using it?
Urbason must not be taken,if you are allergic to methylprednisolone or any of the excipients listed in section 6 of this medicine.
Generally, your doctor will perform a treatment with corticosteroids, such as Urbason, perform in an emergency or in the absence of endogenous cortisol when.:
You have a stomach or duodenal ulcer,
They suffer from severe osteoporosis,
You have (even if this has occurred only in the past) a mental illness,
They suffer from certain acute viral diseases (herpes disease, shingles, chickenpox)
You have received a vaccination or 2 weeks before the such can be obtained over the next eight weeks,
You have within the last 12 months a BCG (tuberculosis) vaccine received,
They suffer from a disease caused by parasites (eg. As amoeba)
They suffer from a fungal disease that affects the entire body,
They suffer from polio (excluding the bulbärenzephalitische form)
They vaccination suffer from a disease of the lymph nodes after BCG (tuberculosis)
You suffer from glaucoma,
You suffer from a muscle disease,
They have a tuberculosis unhandled,
They suffer from a specific inflammation of the cornea in the eye ( "herpetic keratitis"),
the patient is younger than 6 years.
Warnings and Precautions
Please talk to your doctor or pharmacist before taking Urbason.Before starting treatment with Urbason:
Please inform your doctor before starting treatment if you suffer from any of the following diseases:
chronic hepatitis, with hepatitis viruses are detectable (HBsAg-positive),
Lymph nodes hardening - up to one year after a BCG (tuberculosis) vaccine, the doctor will check whether certain white blood cells (called histiocytes) occur frequently,
bacterial infections,
if you were previously contracted tuberculosis because the doctor is the Urbason treatment only perform along with a tuberculosis protection (treatment with Urbason could otherwise lead to a new outbreak of tuberculosis)
High blood pressure,
Diabetes,
Corneal ulcers, sores on the eye.
In the above cases, the doctor Urbason will apply only after careful benefit-risk assessment. If necessary, it will also cause a treatment of these diseases.
To avoid the risk of damage to the intestinal wall or a perforated ulcer, you must inform your doctor about bowel disease or intestinal surgery, namely:
in severe inflammation of the colon (known as "ulcerative colitis" with imminent breakthrough, abscesses or purulent inflammation),
in certain other intestinal inflammation (so-called "diverticulitis"),
if you have recently had a colostomy was performed.
The signs of peritoneal irritation to gastric or intestinal perforation may be absent in patients who receive high glucocorticoid doses.
During treatment with Urbason:
Methylprednisolone may affect carbohydrate metabolism and thereby worsen an existing diabetes. Your doctor will adapt or initiate a diabetes treatment if necessary.
If you have high blood pressure, regular monitoring is necessary during Urbason treatment.
During a severe heart condition, you will monitor your doctor to detect a deterioration in time.
An existing muscle disease (so-called "myasthenia gravis") may temporarily worsen at the start of Urbason treatment.
Treatment with Urbason can weaken the immune system, thereby increasing the risk of infection. At the same time the signs of infection may be obscured and therefore complicate the appropriate diagnosis.
Certain viral infections may by systemic treatment with glucocorticoids, other than those made on the basis of insufficient or lack of function of the adrenal cortex, be serious and sometimes life-threatening.
Systemic glucocorticoid therapy can cause, in very rare cases, diseases of the retina of the eye (so-called "chorioretinopathy") and resulted in impaired vision through to vision loss. Such diseases of the retina may occur with systemic glucocorticoid therapy duration at low dose levels.
Vaccinations with so-called "inactivated vaccines" are possible, the success of the vaccination may also be weakened.
If you receive a high-dose treatment with Urbason, your doctor may order an additional intake of potassium and a restriction in sodium intake and monitor the potassium serum levels.
Viral diseases such as measles, chicken pox or shingles can be more severe by treatment with glucocorticoids. Affected are v. A. Children with weakened immune systems and people who had no corresponding infection. If it comes with Urbason in these patients during treatment to a contact with an infected person, the doctor should be informed. He can then initiate a preventive treatment.
Prolonged treatment with Urbason
Children and adolescents
Since methylprednisolone barrier to its growth is the doctor in children who have to be treated for long periods with Urbason, monitor the growth.
If you receive Urbason a long time, your doctor may request regular ophthalmological controls (every 3 months) and X-ray examinations of the spine.
If you during Urbason treatment in a special stress situation fall (z. B. accident, surgery, childbirth), a temporary increase of the dose may be necessary. Thus, please tell the doctor.
Depending on the duration and dosage of treatment may decrease bone density, so your doctor will recommend a prevention of osteoporosis when needed. It consists in sufficient calcium and vitamin D intake and physical activity. If you already suffer from osteoporosis, your doctor may also perform a drug therapy.
At the end of a longer Urbason treatment Your doctor will gradually reduce the dose. This withdrawal symptoms, the resurgence of the disease being treated and a possible functional weakness of the adrenal cortex are avoided. In addition to a rapid reduction of the dose leading to muscle and joint pain.
If you change your doctor (z. B. in operations when traveling or vaccinations), you must inform him about your treatment with Urbason.
Very rarely can occur during glucocorticoid treatment for liver disorders that usually go away after completion of therapy. The doctor may thus present a check your liver enzymes in the blood.
If you have a hormone-producing tumor of the adrenal medulla (pheochromocytoma), should be undertaken only after appropriate evaluation of the risk-benefit ratio by the doctor a Urbason treatment. There were cases of pheochromocytoma crises (arterial hypertension, headache, sweating and pale of the skin) after glucocorticoid treatment, some with fatal outcome, reported.
The use of this product may Urbason in doping controls lead to positive results.
Taking Urbason with other medicines
Tell your doctor or pharmacist if you are taking other medicines / apply, have recently taken / used any other medicines or are considering taking other medicines / apply.
The following drugs and / or drugs may reduce the effect of Urbason:
Agents that activate certain liver enzymes (so-called CYP3A4 enzymes), z. B .: rifampicin (used to treat tuberculosis), phenytoin, carbamazepine, barbiturates, primidone (medicines used to treat epilepsy) or ephedrine (medicines z. B. against Cough and sneeze).
Aluminum containing medicines to neutralize the stomach acid (heartburn) may decrease the effect of Urbason and should therefore be taken only at intervals of 2 hours.
The following drugs and / or drugs can increase the effects of Urbason:
Agents that certain liver enzymes (so-called CYP3A4 enzymes) inhibit, z. B .: ketoconazole, itraconazole (medicines used to treat fungal infections) and hormonal contraceptives (the "pill").
Urbason may increase the effect of other drugs:
Certain cardiac drugs (so-called "heart glycosides"), certain drugs for muscle relaxation (so-called "non-depolarizing muscle").
Urbason can reduce the effect of other medicines:
Glucose-lowering drugs, antiplatelet medicine taken by mouth, praziquantel (anthelmintics), somatropin (growth hormone).
Further interactions exist with the following drugs and diagnostic agents:
Diuretic Arzneimiittel and laxatives: Potassium excretion is enhanced.
Anti-inflammatory, analgesic drugs and rheumatic drugs (so-called NSAIDs, NSAID): increased risk of gastrointestinal bleeding and ulcers.
Atropine and other so-called "anticholinergics" (drugs that act on specific parts of the nervous system): additional increase in intraocular pressure.
Malaria drugs (chloroquine, hydroxychloroquine, mefloquine): increased risk of muscle and heart muscle diseases.
Protirelin (medicines for thyroid diagnosis): The increase of thyroid hormone TSH may be reduced.
Cyclosporins (medicines that affect the immune system): increased risk of seizures.
Certain antihypertensives (called "ACE inhibitors"): increased risk of blood disorders.
Diltiazem (calcium antagonist drugs for cardiovascular diseases): The metabolism of Urbason is inhibited, thereby a dose adjustment may be necessary.
Allergy testing: Skin reactions in so-called 'skin prick test' can be suppressed.
pregnancy and breast feeding period
If you are pregnant or breastfeeding or if you suspect you may be pregnant, or planning to become pregnant, ask before taking this medicine your doctor or pharmacist for advice.Pregnancy:
During pregnancy, especially in the first three months, your doctor will carry out a treatment only after careful benefit-risk assessment. Therefore, women must seek medical attention from an existing or newly joined pregnancy or the possibility of pregnancy.
Lactation:
Glucocorticoids are excreted into breast milk. If treatment with higher doses or long-term treatment is required, should therefore be discontinued.
Driving and using machines
Note: This medicine may interfere with the responsiveness and ability to drive.
During treatment with Urbason the active participation in traffic or operating machinery be impaired in rare cases by certain side effects (eg. As blurred vision, dizziness or headache).
Urbason contains 136 mg of lactose (milk sugar)
Please Urbason only after consultation with your doctor if you know that you have an intolerance to some sugars.
How is it used?
Take this medicine exactly as your doctor has told a. Ask yourself if you are not sure with your doctor or pharmacist.Your doctor will calculate the dose individually, depending on the type and severity of the condition, adjust. For the stated quantity is also Urbason are 4 mg tablets.
Adult:
Initiation of treatment: 12-80 mg methylprednisolone per day (ie 3 Urbason 4 mg tablet up to 5 Urbason 16 mg tablets daily).
During treatment: 4-8 mg methylprednisolone per day (ie 1-2 Urbason 4 mg tablets), briefly up to 16 mg methylprednisolone per day (ie 4 Urbason 4 mg tablets).
Dosage in Addison'scher disease: 4-8 mg methylprednisolone per day (ie 1-2 Urbason 4 mg tablets) in addition to Mineralokortikosteroidtherapie.
The maximum daily dose of 80 mg methylprednisolone (corresponding to 5 Urbason 16 mg tablets and 20 mg tablets Urbason 4) must not be exceeded.
Use in children and adolescents
Adolescents and children over 6 years:
Initiation of treatment: daily 0.8-1.5 mg methylprednisolone per kg body weight.
During treatment: 2-4 mg methylprednisolone per day (that is ½ to 1 Urbason 4 mg tablet), briefly up to 8 mg daily (ie up to 2 Urbason 4 mg tablets).
Cirrhotic patients or underactive thyroid:
The doctor may prescribe a lower dose indicated as above.
type of application
To take.
The tablets should be swallowed whole during or after a meal, preferably after breakfast, with sufficient liquid (eg. A glass of water).
Duration of treatment
About the method of administration, which depends on the type and severity of the disease, your doctor will decide.
If you take more of Urbason than you should
Acute poisoning with Urbason are not known and can not be expected. However, (glands, metabolism, electrolyte balance are affected v. a.) In very rare cases, as with other glucocorticoids, side effects. In these cases, a doctor should be contacted immediately. Treating the symptoms will be based on the symptoms.
If you forget to take Urbason
Do not take a double dose if you have forgotten dose.
If you stop taking Urbason
If the treatment is stopped prematurely, the success of the therapy is in danger. In addition, there may be a suspension of adrenal function or withdrawal symptoms.
If you have further questions about taking this medicine, contact your doctor or pharmacist.
What are possible side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets them.Frequencies are defined as follows:
Rare (may affect up to 1 in 1,000)
Very rare (may affect up to 1 in 10,000)
Not known (can not be estimated from the available data)
infections
Not breaking an existing infection, outbreak of a previously unrecognized infection.
blood
Blood disorders: at the beginning of the treatment transient proliferation of certain white blood cells (leukocytosis), shortage of certain white blood cells (lymphopenia, eosinopenia), increasing red blood cell count, increased formation of blood platelets, decreased production of platelets, increased risk of dangerous blood clots (thrombosis) to develop.
immune system
Very rare: weakened immune system, resulting in increased risk of infection; allergic reaction; Hypersensitivity reactions to the shock (particularly in patients with asthma and kidney transplantation).
endocrine system
Changes in the adrenal cortex, so-called "Cushing's syndrome" (moon face, proliferation of adipose tissue), growth inhibition in children.
Very rare: disorders of sex hormones (absence of menstruation, increased hair growth, impotence).
Unknown: pheochromocytoma crisis, which is characterized by the following symptoms: hypertension, headache, sweating and pale of the skin.
Metabolism and nutrition disorders
Decreased sodium excretion, thereby swelling and water retention, increased potassium excretion (may result in the u. U. to cardiac arrhythmias and hypertension), weight gain, higher blood sugar levels after eating (impaired glucose tolerance), diabetes, elevated cholesterol and triglyceride levels, increased protein degradation.
Very rare: transient increase in adipose tissue (dura mater, heart, middle chest).
Mental disorders
For example, depression, increased living and happiness, personality changes, mood swings; Irritation, drive and increased appetite.
nervous system
Seizures, insomnia, dizziness, headache, increase in intracranial pressure (especially in children), incidence of previously unrecognized seizures or increased tendency to convulsions.
eyes
Gray or glaucoma, exacerbation of existing corneal ulcer, favoring eye infections caused by viruses, fungi or bacteria.
Unknown: blurred vision increased intraocular pressure, diseases of the retina and the choroid (chorioretinopathy).
heart
In patients with existing heart disease: increased pulmonary congestion.
blood vessels
Increased tendency to tear the smallest blood vessels, inflammation of small blood vessels (also known as withdrawal symptoms), high blood pressure, increased risk of atherosclerosis (atherosclerosis), increased risk of thrombosis.
Unknown: increased blood clotting.
Gastrointestinal tract
Gastrointestinal ulcers (risk of perforation), bleeding, inflammation of the pancreas, epigastric discomfort.
Hepatobiliary disorders
Unknown: increase of liver enzymes.
skin
Reddish stretch marks, "thinning" of the skin, enlargement of small blood vessels, punctate or larger ecchymosis, increased hair growth, "cortisone Acne", delayed wound healing, skin inflammation around the mouth, change in skin pigmentation
Rare: hypersensitivity (. Eg drug rash).
Muscles, tendons and bones
Muscle wasting and weakness, acute muscle disease (myopathy) with additional use of certain drugs for muscle relaxation (so-called "non-depolarizing muscle"), bone loss (osteoporosis), death of bone tissue, tendon rupture. If after a long term treatment the dose reduced too quickly, it may come in patients with rheumatic diseases to temporary muscle and joint pain.
Reporting of adverse reactions
If you notice any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed in this description.
How should it be stored?
This medicinal product does not require special storage conditions.Keep this medicine out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines when you are done using it. These measures will help to protect the environment.
Further information
What Urbason contains 16 mgThe active substance is methylprednisolone. Each tablet contains 16 mg of methylprednisolone.
The other ingredients are lactose monohydrate, maize starch, povidone 25000, talc, magnesium stearate.
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